Kornimate/medical-research-clean huggingface dataset:
a study to compare the effect of asp3550 with goserelin in patients with prostate cancer

Conditions: Prostate Cancer

Summary: to compare the efficacy and safety of asp3550 to goserelin acetate in patients with prostate cancer.

this study consists of two parts. the purpose of part 1 is to test non-inferiority of asp3550 to goserelin acetate with respect to the cumulative castration rate in terms of serum testosterone when asp3550 or goserelin acetate is administered for one-year in patients with prostate cancer. the patients assigned to receive asp3550 and completed the treatment in part 1 are eligible for the treatment in part 2, and will receive asp3550 maintenance dose subcutaneously for additional term. the long-term safety, efficacy and pk of the continued asp3550 treatment will be assessed in part 2.

Eligibility criteria:
inclusion criteria: * male patient with histologically confirmed prostate cancer (adenocarcinoma). * patient in whom endocrine treatment is indicated. patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum psa (psa ≥ 2 ng/ml at screening) may be included. * has a serum testosterone level above 2.2 ng/ml at screening. * has an eastern cooperative oncology group (ecog) performance status (ps) score of 0 to 2 at screening. * has a serum psa ≥ 2 ng/ml at screening. * has a life expectancy of at least 12 months. exclusion criteria: * previous or present endocrine treatment for prostate cancer. example: surgical castration, gnrh agonists, gnrh antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors. * received a 5α-reductase inhibitor within 25 weeks preceding screening. * is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months. * has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema. * has hypersensitivity towards mannitol. * has a marked prolongation of qt/qtc interval (two consecutive increases to \>450 ms in qtc interval at retest) at screening. * has concurrent or a history of a disease (heart failure, hypokalemia, a family history of qt prolongation syndrome, etc.) that may induce torsade de pointes.

Keywords: asp3550 prostate cancer
efficacy and safety of osimertinib for hk chinese with metastatic t790m mutated nsclc-real world setting.

Conditions: Non-small Cell Lung Cancer

Summary: to assess the efficacy of single-agent osimertinib in relation to egfr t790m mutant allele fraction (af) in a real-world setting.

this study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic egfr t790m-positive nsclc within the context of the early access program in hong kong. in particular, osimertinib treatment efficacy will be assessed in the context of the relationship between egfr t790m mutant af and survival outcomes, particularly overall survival. in a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. other clinical outcomes including response rate (based on physician's judgement) and time to treatment discontinuation (ttd) will be examined. this study will also describe current practice for molecular testing and egfr mutation profiles in this patient population.

Eligibility criteria:
inclusion criteria: * patients enrolled in azd9291 named patient program in hong kong * patients with confirmed advanced (locally advanced (stage iiib) or metastatic (stage iv)) nsclc with a positive test result for the egfr t790m mutation * patients who have previously received egfr tki therapy or discontinued an egfr tki at the time of enrolment in the study * provision of written informed consent (for patients alive at the time of study enrolment) * documented patients with trackable medical records exclusion criteria: * enrolment in studies that prohibit any participation in this non-interventional study
bipolar rfa of painful extra-spinal bone metastases

Conditions: Multi-metastatic Cancer

Summary: to evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (rfa) performed with the osteocool system.


Eligibility criteria:
inclusion criteria: * 1) multi-metastatic cancer patients with at least one painful lytic bone metastasis * 2) target lesion should correspond to a specific radiologic finding * 3) at least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation * 4) patients 18 years old * 5) able to give written consent * 6) life expectancy 1 months * 7) patient affiliated to the national health insurance system exclusion criteria: 1. radiation therapy on the target tumor terminated \< 3 weeks before treatment 2. any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk 3. any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk 4. impaired haemostasis 5. concurrent participation in other experimental studies that could affect endpoints of this study 6. contraindication to any form of sedation/anaesthesia 7. signs of local/systemic infection identified before procedure, in accordance with standard care 8. sclerotic metastases 9. adults under guardianship 10. patients under judicial protection 11. pregnant or breastfeeding woman

Keywords: pain extra-spinal rfa radiofrequency ablation bone metastases
efficacy of roflumilast in the treatment of psoriasis

Conditions: Psoriasis

Summary: roflumilast (daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (pde4), is used for severe chronic obstructive pulmonary disease. recent research suggest roflumilast is effective in treating psoriasis. the aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. this has not previously been done.

aim: to investigate the efficacy of roflumilast in the treatment of psoriasis. design: multicentre, double-blinded, randomised, placebo-controlled, clinical trial. participants: patients ≥18 years with plaque psoriasis. method: twelve weeks treatment with either roflumilast or placebo tablets. both groups continue for an additional 12 weeks open-label treatment. primary endpoint: proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (pasi75) at week 12.

Eligibility criteria:
inclusion criteria: * age ≥18 years * chronic stable plaque psoriasis (min duration 6 months) * pasi \>8 * body mass index (bmi) \> 20 kg/m2 * candidate for systemic treatment of psoriasis * negative pregnancy test (only women) * safe anticonception during entire study and at least 1 week after end of treatment (\~5 times plasma half-life of roflumilast) (only applying for fertile women) exclusion criteria: * severe immunological disease, e.g. hiv, systemic lupus, and systemic sclerosis * current tuberculosis * current viral hepatitis * heart failure (nyha iii-iv) * moderate or severe liver failure (child-pugh b-c) * current or former malignancy (basal cell carcinoma excluded) * current or former depression with suicidal ideation * topical therapy for psoriasis during within 2 of randomization or during study * systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of randomization or during study * treatment with theophylline, phenobarbital, carbamazepine, or phenytoin * confirmed pregnancy * planned pregnancy within 6 months * breast feeding * blood donation during study * inability to complete study
study of high risk non invasive prenatal test population

Conditions: Trisomy 21

Summary: the investigator want to study the population of high risk (over 1/50) of trisomy 21. according to french guidelines, these patients needs to have a invasive test (such as amniocentesis) but some patients prefer to have a non invasive prenatal test, with a potential lack of information.


Eligibility criteria:
inclusion criteria: * prenatal screening of trisomy 21 \> 1/50 (high risk population) exclusion criteria: * no exclusion criteria
phase i study of u3p1287/01, including patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of u3-1287 (amg 888), a fully human monoclonal antibody targeting the her3 receptor, in patients with advanced solid tumors. eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. the study will be conducted in two parts; a dose escalation (part 1) and a dose expansion (part 2). the hypothesis for this study is that u3-1287 (amg888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.


Eligibility criteria:
key inclusion criteria: * pathologically or cytologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the patient refuses standard therapy. * eastern cooperative oncology group (ecog) performance status ≤ 2. * men or women at least 18 years of age * adequate hematologic, cardiac, renal, hepatic, metabolic, and coagulation function key exclusion criteria: * presence of untreated or symptomatic brain metastasis. * presence of ascites or pleural effusion requiring chronic medical intervention. * uncontrolled hypertension * concurrent or previous (within 1 week of study day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low dose,low molecular weight heparin for prophylaxis against central venous catheter thrombosis. * recent major surgical procedure or not yet recovered from major surgery * recent participation in clinical drug trials. * participation in other investigational procedures. * unresolved toxicities from prior anti-cancer therapy * patient who is pregnant (e.g. positive human choriogonadotropin \[hcg\] test) or nursing.

Keywords: human epidermal growth factor receptor 3 her3 heregulin erb b3 solid tumors phase i clinical study
the effect of the crossword used in nursing education on learning success

Conditions: Pain; Nursing; Crossword

Summary: the research was planned as a randomized controlled study to evaluate the effect of crossword, which are an active learning tool, on the success of learning information about pain control in nursing education. research data is planned to be collected in hatay mustafa kemal university faculty of health sciences. the universe of the research will be the students who take the 3-credit pain control course in the aforementioned faculty in the fall semester. the sample of the research will consist of 72 students who meet the inclusion criteria and agree to participate in the research verbally and in writing. the data of the research will be collected by using the personal information form prepared in line with the literature, and success tests (3 tests) prepared separately for each stage. spss program will be used in the analysis of the data.


Eligibility criteria:
inclusion criteria: * to be registered in the pain course, * taking the pain course for the first time, * absence of any psychiatric disorder that will reduce the ability to comprehend and understand, * agreeing to participate in the research. exclusion criteria: -willingness to leave the research
is combined steroid and sodium hyaluronate hydrodilatation more effective than isolated steroid hydrodilatation in treating patients with adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: this study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.

design: a prospective, double-blinded, randomized, clinical trial patient and methods: patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). the patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. outcomes measures included a pain scale (visual analog scale), range of motion, shoulder pain and disability index

Eligibility criteria:
inclusion criteria: 1. age 35-65 years 2. onset of shoulder stiffness since over a month 3. limitation in the passive range of motion (rom) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation. exclusion criteria: 1. ultrasound findings of rotator cuff tears, 2. plain radiography findings of significant glenohumeral joint arthritis, 3. accompanying cervical radiculopathy, 4. systemic inflammatory joint disease, 5. intraarticular injection into the glenohumeral joint within the past 3 months 6. history of surgery on the affected shoulders, 7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, 8. allergy to corticosteroid or lidocaine.
alpha-synuclein pet/ct in various α-syn-related disease

Conditions: Alpha Synuclein Pathology; Alpha-Synuclein; Parkinson Disease

Summary: to evaluate the potential usefulness of 18f-fiat-2, 18f-c05-05, 18f-spal-t-06 positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions in various α-syn-related disease patients.

subjects with various α-syn-related disease patients underwent 18f-fiat-2, 18f-c05-05, 18f-spal-t-06 pet/ct either for an initial assessment or for recurrence detection. lesions uptake was quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 18f-fiat-2, 18f-c05-05, 18f-spal-t-06 pet/ct were calculated.

Eligibility criteria:
inclusion criteria: * (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated pd (supporting evidence may include mri, ct, tumor markers and pathology report); (iii) patients who had scheduled α-syn pet/ct scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: * (i) patients with none pd syndrome; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Keywords: pet/ct mri alpha-synuclein
rabeprazole in subjects with gastroesophageal reflux disease (gerd)

Conditions: Esophageal Reflux

Summary: the purpose of this study is to determine the production of mucin in gerd/re subjects before and after 8 weeks of treatment with rabeprazole.

enrolled patients will undergo collection of salivary and esophageal secretions. subsequently, all patients will receive rabeprazole (20mg qd) for 8 weeks and will be re-endoscoped to confirm complete healing of reflux esophagitis. in patients with completely healed reflux esophagitis the second collection of salivary and esophageal secretion will be implemented. in both secretions, adequately coded for the laboratory research fellow (blinded in terms of which sample is collected before and which after treatment with rabeprazole) the content of mucin will be measured using commercially available assay and its secretion expressed in units per minute of collection time.

Eligibility criteria:
inclusion criteria: 24 patients with endoscopically confirmed reflux esophagitis (grades a-d according to la classification) in patients with chronic symptoms of gerd (heartburn with or without regurgitation) between the age of 19 and 79, 12m \& 12f, will be included. exclusion criteria: history of gi surgery, primary esophageal motor disorders, any systemic disease, history of drug or alcohol abuse, pregnancy or nursing, allergy to the same drug class as rabeprazole, the need for any concurrent therapy that affects salivary secretion (causing so-called "dry mouth syndrome").
bg00012 monotherapy safety and efficacy extension study in multiple sclerosis (ms)

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary objective of this study is to evaluate the long-term safety profile of bg00012 (dimethyl fumarate). secondary objectives of this study are to evaluate the long-term efficacy of bg00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of bg00012 on multiple sclerosis (ms) brain lesions on magnetic resonance imaging (mri) scans in participants who had mri scans as part of studies 109ms301 (nct00420212) and 109ms302 (nct00451451) and to evaluate the long-term effects of bg00012 on health economics assessments and the visual function test.

the initial bg00012 dosage for the extension study (240 mg bid or 240 mg tid) was the same as that used in the phase 3 studies 109ms301 (nct00420212) and 109ms302 (nct00451451). subsequent to the initiation of this study, bg00012 was approved in several countries for the treatment of ms at a dose of 240 mg bid. for this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg bid.

Eligibility criteria:
key inclusion criteria: -subjects who participated in and completed as per protocol previous bg00012 clinical studies 109ms301 (nct00420212) or 109ms302 (nct00451451). key exclusion criteria: * any significant change in medical history from 109ms301 or 109ms302 that would have excluded subject's participation from their previous study. * subjects from 109ms301 or 109ms302 who discontinued oral study treatment due to an ae or due to reasons other than protocol-defined relapse/disability progression. * subjects from 109ms301 or 109ms302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to week 96. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: relapsing multiple sclerosis remitting oral
a study to assess patient-reported wellbeing using tildrakizumab in a live setting

Conditions: Plaque Psoriasis

Summary: the main purpose of this study to investigate the relationship between clinical symptoms and quality of life (qol) in participants who receive tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (smpc).


Eligibility criteria:
inclusion criteria: * participant with diagnosis of moderate or severe chronic plaque pso documented in the medical chart. * participant who needs systemic biologic therapy and qualifies for treatment with an il-23p19 inhibitor. tildrakizumab must be the anti-il-23p19 selected therapy before including the patient in the study. * participant aged greater than or equal to (\>=) 18 years at inclusion. * written informed consent. exclusion criteria: * participant unable or unwilling to comply with the requirements of the study. * participant who should not participate in the study for any reason at the discretion of the treating physician. * participants participating in a simultaneous clinical trial. * any contraindication against the use of tildrakizumab according to the smpc. * exposure to \>= 3 biologics prior to inclusion. * participant dependent on the investigator, e.g. as employee
inulin,scfa production and metabolic response

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: in this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal scfa production, thereby investigating whether this will lead to acute metabolic effects.

gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. the role of gut-derived short-chain fatty acids (scfa), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. at the present time, our understanding of the effects of scfa on human metabolism (in gut or systemically) is still limited. the investigators hypothesize that the ingested prebiotic inulin is fermented into scfa and these scfa have metabolic effects.

Eligibility criteria:
inclusion criteria: * overweight, obese men exclusion criteria: * athletes * diabetes mellitus
imrt lower limb soft tissue sarcoma

Conditions: Sarcoma

Summary: intensity-modulated radiation therapy may make wound healing problems less likely by 1)precisely shaping the region of high radiation dose to the shape of the tissue which harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the shapes of the normal tissues which are more sensitive to radiation effects.


Eligibility criteria:
inclusion criteria: * histologically proven soft tissue sarcoma * lesion lies between the iliac crest (hipbone) and the ankle * lesion is newly diagnosed * assessed by radiation oncologist and surgical oncologist exclusion criteria: * benign histologies * histologies generally treated with chemotherapy * prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix
therapeutic education and nursing support program for supportive care, in patients treated with hormone therapy for non-metastatic breast cancer

Conditions: Neoplasm of Breast

Summary: to compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (aes) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.

the main objective of the etaph project is to offer breast cancer patients multidisciplinary care that will limit the impact of adverse effects related to hormone therapy treatment and improve their quality of life. the achievement of this objective is based on therapeutic education and nursing follow-up throughout the first year of treatment, which, thanks to active listening and coordination of the various players, will enable global and personalized patient care.

Eligibility criteria:
inclusion criteria: * patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting. * performance status (ecog) ≤ 2 * patient able to read and understand french (common use) * patient with access to an internet connection (for collection of adverse events and responses to questionnaires) * patient who has been informed and has given written consent to participate in the study exclusion criteria: * patient with metastatic cancer * patient undergoing neoadjuvant hormone therapy * patient who started hormone therapy prior to inclusion in the study * patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago. * for patients in the experimental group: inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for geographical, physical or other reasons (at the discretion of the investigator). * for patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education. * pregnant and breastfeeding women * patient with a documented history of cognitive or psychiatric disorders * refusal to participate, protected adult patient, under guardianship or curatorship

Keywords: therapeutic education nursing support program hormone therapy non-metastatic breast cancer breast cancer